Quick-Start Operating Guide
USP 797 Modular Cleanroom
©
Copyright 2015 Terra Universal Inc. All rights reserved. • Revised Dec 2019 • Document No. 1800-90
Terra Universal, Inc. • TerraUniversal.com • 800 S. Raymond Ave. • Fullerton, CA 92831 • TEL: (714) 578-6000 • FAX: (714) 578-6020
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USP 797 Compliant Cleanrooms
Installation and operating instructions in this manual pertain to Terra Modular Cleanrooms designed to comply with the provisions of
USP 797 for sterile compounding. It is recommended that you review this manual in its entirety prior to installation.
These cleanrooms feature Terra’s standard hardwall construction configured in two standard sizes: 6’ x 8’ and 6’ x 10’. Refer to
attached system drawings for details on any custom features specified in your order, including custom dimensions. Standard
designs include a “buffer” area (main processing room) and anteroom (staging/gowning area). These spaces are divided by a swing
door mounted to an internal wall, which maintains the required pressure differential between the two areas.
Modular Hardwall Cleanrooms designed to the requirements of USP 797 feature three Fan Filter Units, which are factory set at
medium speed. At this setting, these systems meet the requirements for internal pressure, air displacement, and cleanliness
specified by USP 797 for both the ISO 7 “buffer room” (main processing room) and ISO 8 ante room (see “Compliance Testing
Protocol” for more information).
Users are typically required to undergo on-site testing and certification by an independent testing company authorized by
the relevant regulating agency. Any data furnished by Terra, including information published in Terra literature or web
pages, do not constitute formal certification to USP 797 or any other specification or regulation.
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Description
Terra Universal’s Modular Cleanroom provides an
economical alternative to high-cost, fixed-installation
cleanrooms while providing the rigidity and durability of a
freestanding room.
Designed to combine economy and versatility, this system
features ceiling HEPA Fan Filter Units (FFUs) that direct a
continuous flow of HEPA or ULPA-filtered air through the
enclosure. The continuous positive pressure created by this
laminar airflow helps to control particles generated inside
the enclosure by sweeping them downward through the
room and out the air vents. This design also helps to
prevent contaminants from entering the cleanroom when
an access door is opened.
Proprietary Notice
This manual pertains to proprietary devices manufactured by Terra
Universal, Inc. Neither this document nor any portion of it may be
reproduced in any way without prior written permission from Terra
Universal.
Terra Universal makes no warranties applying to information contained
in this manual or its suitability for any implied or inferred purpose.
Terra Universal shall not be held liable for any errors this manual
contains or for any damages that result from its use. The information
presented here is subject to change without notice.
Safety Notice
A thorough familiarity with all operating guidelines is essential to safe
operation of the product. Failure to observe safety precautions could
result in poor performance, damage to the system or other property, or
serious bodily injury or death.
The following symbols are intended to call your attention to two levels
of hazard involved in operation:
Cautions are used when failure to observe instructions
could result in significant damage to equipment.
CAUTION
Warnings are used when failure to observe instructions
or precautions could result in injury or death.
WARNING
ISO 7 Buffer Room of Terra Universal’s USP 797 Cleanroom. Depending
on specified dimensions, your cleanroom may be configured differently.
Glovebox, hood and other furnishings not included.
